Multiphase Optimization Strategy (MOST) for Treating Pediatric Post-traumatic Stress Disorder (PTSD)

Официальное название

Optimizing Behavioral Health Services Following Pediatric Trauma Exposure

Обзор

The goal of this clinical trial is to test the extent to which different treatment components work to improve pediatric post-traumatic stress disorder (PTSD). It will also provide evidence for how these components work. The main research questions are: What are the effects of different components used to treat PTSD? What do these components change to produce benefits in PTSD? Researchers will: Compare components to a psychological placebo to estimate their effects and measure how they work Examine how components work alone and in conjunction with other components Participants will: Receive different combinations of components and placebo Attend weekly treatment sessions Provide information to evaluate changes in PTSD

Вмешательства

• Поведенческое Emotion Regulation
  Participants learn to reduce acute subjective distress, stabilize negative mood, promote positive mood, and alter physiological responses to trauma
• Поведенческое Exposure
  Participants engage in written exercises to reduce avoidance of trauma reminders and reinforce approach behaviors consistent with personal goals
• Поведенческое Cognitive Processing
  Participants learn ways to identify, challenge, and overcome the influence of cognitive distortions resulting from trauma exposure
• Поведенческое Bi-lateral Stimulation
  Participants engage in horizontal eye movements while recalling a traumatic memory and describing their affective and physiological state
• Поведенческое Psychological Placebo
  Participants receive non-directive support therapy, where they will guide the treatment session but not be required to discuss prior trauma exposure

Первичные конечные точки

• Mean Change in PTSD Symptoms - Clinician Administered PTSD Scale for DSM-5 - Child/Adolescent Version (CAPS-CA) [Срок оценки: Baseline (pre-treatment), Week 19 (post-treatment)]
• Mean Change in PTSD Symptoms - Child PTSD Symptom Scale for DSM-5 (CPSS) [Срок оценки: Baseline (pre-treatment), Week 19 (post-treatment)]
• Mean Change in PTSD Symptoms - Child and Adolescent Trauma Screen (CATS-2) [Срок оценки: Baseline (pre-treatment), Week 19 (post-treatment)]

Вторичные конечные точки (12)

• Change in the Number of Participants with a PTSD Diagnosis - The Clinician Administered PTSD Scale for DSM-5 - Child / Adolescent Version (CAPS-CA) [Срок оценки: Baseline (pre-treatment), Week 19 (post-treatment)]
• Change in PTSD Symptom Trajectories - Child PTSD Symptom Scale for DSM-5 (CPSS) [Срок оценки: Baseline (pre-treatment), Weeks 1-18 (active treatment), Week 19 (post-treatment)]
• Change in PTSD Symptom Trajectories - Child and Adolescent Trauma Screen (CATS-2) [Срок оценки: Baseline (pre-treatment), Weeks 1-18 (active treatment), Week 19 (post-treatment)]
• Mean Change in Mood Disorder Symptoms - Children's Depression Inventory-2 (CDI-2) [Срок оценки: Baseline (pre-treatment), Week 19 (post-treatment)]
• Mean Change in Anxiety Disorder Symptoms - Screen for Child Anxiety Related Disorders (SCARED) [Срок оценки: Baseline (pre-treatment, Week 19 (post-treatment)]
• Mean Change in Disruptive Behavior Disorder Symptoms - Child Behavior Checklist (CBCL) [Срок оценки: Baseline (pre-treatment), Week 19 (post-treatment)]
• Change in PTSD, Mood, Anxiety, and Disruptive Behavior Disorder Symptom Trajectories - Ecological Momentary Assessment (EMA) [Срок оценки: Baseline (pre-treatment), A randomly selected two-week period during active treatment (Weeks 5-18), Week 19 (post-treatment)]
• Changes in Trajectories of C-Reactive Protein (CRP) [Срок оценки: Baseline (pre-treatment), A randomly selected two-week period during active treatment (Weeks 5-18), Week 19 (post-treatment)]
• Changes in Trajectories of Interleukin-6 (IL-6) [Срок оценки: Baseline (pre-treatment), A randomly selected two-week period during active treatment (Weeks 5-18), Week 19 (post-treatment)]
• Changes in Trajectories of Tumor Necrosis Factor-Alpha [Срок оценки: Baseline (pre-treatment), A randomly selected two-week period during active treatment (Weeks 5-18), Week 19 (post-treatment)]
• Brain Aging - Magnetic Resonance Imaging (MRI) [Срок оценки: Baseline (pre-treatment), A randomly selected two-week period during active treatment (Weeks 5-18), Week 19 (post-treatment)]
• Change in Neural Structure - Magnetic Resonance Imaging (MRI) [Срок оценки: Baseline (pre-treatment), A randomly selected two-week period during active treatment (Weeks 5-18), Week 19 (post-treatment)]

Критерии участия

Критерии включения

A child between the ages of 8-17 exposed to at least one DSM-defined trauma

Child assent for participation

The participation of a caregiver with custodial rights to provide parental permission

Willing to participate in treatment delivery and respond to surveys

Meet PTSD diagnostic criteria that is the result of exposure to at least one of the identified traumas

Ability to read and understand English

Willingness to be randomized to an experimental condition

Placement in a stable caregiving environment for two months without an impending transition

Children currently taking psychotropic medications must have taken the medicine without dose adjustment for two months prior to study entry.

Caregiver or child with a smartphone capable of downloading a freely available software application.

Критерии исключения

Psychiatric concerns requiring a higher level of care (e.g. suicidal ideation with intent; current psychotic disorder)

An intelligence quotient (IQ) < 70

Currently receiving a behavioral health intervention for concerns related to PTSD or pediatric trauma

A participating caregiver who is a perpetrator of any identified trauma (e.g. sexual abuse)

MRI contraindicators (e.g. presence of metal in the body)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• The Mt. Hope Family Center — Rochester

Идентификаторы

NCT: NCT06956781 · STUDY00010448

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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